A study protocol for HEalth-Related quality of life-intervention in survivors of Breast and other cancers experiencing cancer-related fatigue using TraditionAL Chinese Medicine: the HERBAL trial

Ning Yi Yap,Quan Ming Tan,Kiley Wei-Jen Loh,Chia Jie Tan,Alexandre Chan,Han Kiat Ho,Wei Sheng Loo,Yi Long Toh,Tira Jing Ying Tan,Lita Chew,Veronique Kiak Mien Tan,Tze Kiat Tan,Seng Kok Ang,Leona Yan Peng Quek,Chiu Chin Ng,Huang Fang Zheng

doi:10.1186/s13063-020-04810-4

Abstract

BackgroundCancer-related fatigue (CRF) is a debilitating condition which commonly affects cancer survivors. The management of CRF remains a challenge due to the lack of effective pharmacological interventions. Traditional Chinese medicine (TCM) could be a potential therapeutic option for CRF. The modified Xiang Bei Yang Rong Tang (XBYRT) is a TCM herbal decoction, formulated to improve fatigue symptoms in cancer survivors. This clinical trial aims to evaluate the efficacy and safety of XBYRT in improving CRF and quality of life (QOL) of cancer survivors.MethodsThis is a single centre, randomized, double-blind, placebo-controlled, parallel trial. Eighty cancer survivors will be recruited and randomized to receive the XBYRT or placebo decoction, in a ratio of 1:1. Participants will consume the XBYRT/placebo decoction daily for 8 weeks and undergo assessments at baseline and 4, 8 and 10 weeks after baseline. The participants will be assessed for patient-reported outcomes (PRO), blood biomarkers and adverse events at each time point. The primary outcome is the overall health and QOL status, at 8 weeks follow-up. The secondary outcomes are the effects of XBYRT on fatigue levels, cancer-related cognitive impairment and QOL, as assessed by PRO. The incidence of adverse events and the effects of the XBYRT decoction on blood biomarkers associated with CRF will also be evaluated.DiscussionEfficacy and safety outcomes from this trial will provide important clinical data to guide future large-scale randomized controlled trials, and the evaluation of the objective blood biomarkers can help to delineate the biological mechanisms of CRF.Trial registration numberClinicalTrials.govNCT04104113. Registered on 26 September 2019

Highlights

Advances in diagnosis and treatment have resulted in better survival rates and an increase in the number of cancer survivors [1]
A total of 80 cancer survivors will be enrolled from the outpatient oncology clinics at the National Cancer Centre Singapore (NCCS), and the recruitment and followup period for this trial will be from October 2019 to December 2021
One of the main Traditional Chinese medicine (TCM) uses of Radix Paeoniae Alba is to treat blood deficiency, and an in vivo investigation has demonstrated that Radix Paeoniae Alba extract increased haemoglobin, haematocrit and serum erythropoietin in anaemia-induced rats [44]

Summary

Introduction

Advances in diagnosis and treatment have resulted in better survival rates and an increase in the number of cancer survivors [1]. The pathophysiology and mechanisms leading to CRF and the factors causing persistent fatigue in cancer survivors are not well understood, despite it being a highly prevalent symptom in cancer patients and survivors. This is because the pathophysiology underlying CRF is complex involving psychological, physical and biological factors. The modified Xiang Bei Yang Rong Tang (XBYRT) is a TCM herbal decoction, formulated to improve fatigue symptoms in cancer survivors This clinical trial aims to evaluate the efficacy and safety of XBYRT in improving CRF and quality of life (QOL) of cancer survivors

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